DDR Capsule
Dexlansoprazole INN
COMPOSITION WARNINGS AND PRECAUTIONS
DDR 30 Capsule : Each capsule contains Dexlansoprazole INN 30 mg as enteric coated Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagne-
pellets. semia, and concomitant use of Dexlansoprazole with Methotrexate.
DDR 60 Capsule : Each capsule contains Dexlansoprazole INN 60 mg as enteric coated
pellets. SIDE EFFECTS
Common side effects : Diarrhea, abdominal pain, nausea, vomiting & flatulence.
PHARMACOLOGY Rare side effects : No data available.
DDR (Dexlansoprazole) delayed-release capsule is a Proton Pump Inhibitor (PPI) which
suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric USE IN PREGNANCY AND LACTATION
parietal cell. By acting specifically on the proton pump, DDR (Dexlansoprazole) blocks the Pregnancy : Pregnancy Category B. There is no adequate and well-controlled studies with
final step of acid production. Dexlansoprazole is the R-enantiomer of lansoprazole (A Dexlansoprazole in pregnant women.
racemic mixture of the R- and S-enantiomers). DDR (Dexlansoprazole) is supplied as a Dual Lactation : There is no adequate and well-controlled studies with Dexlansoprazole in
Delayed Release (DDR) formulation in a capsule for oral administration. DDR (Dexlansopra- lactating mother.
zole) capsule contains a mixture of two types of enteric coated granules with different
pH-dependent dissolution profiles. The dual delayed release formulation of DDR results in a USE IN CHILDREN & ADOLESCENTS
dexlansoprazole plasma concentration-time profile with two distinct peaks; the first peak Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been
occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After established.
oral administration, mean Cmax and AUC value of Dexlansoprazole increased approximately
dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated GARIATRIC USE
by urine. No dose adjustment is necessary for elderly patients.
INDICATIONS RENAL IMPAIRMENT
Healing of Erosive Esophagitis : No dose adjustment of Dexlansoprazole is necessary for patients with renal impairment.
DDR (Dexlansoprazole) is indicated for healing of all grades of erosive esophagitis (EE) for
up to 8 weeks. HEPATIC IMPAIRMENT
Maintenance of Healed Erosive Esophagitis : No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic
DDR (Dexlansoprazole) is indicated to maintain healing of EE and relief of heartburn for up impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for
to 6 months. patients with moderate hepatic impairment.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease :
DDR (Dexlansoprazole) is indicated for the treatment of heartburn associated with DRUG INTERACTIONS
symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks. With medicine : Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate.
With food & others : No data available.
DOSAGE AND ADMINISTRATION
Route of administration : Oral. OVERDOSE
DDR (Dexlansoprazole) Dosing Recommendations : There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of
Maintenance of Healed EE and relief of heartburn : 30 mg Once daily Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in
Symptomatic Non-Erosive GERD : 30 mg Once daily for 4 weeks death or other severe adverse events.
Healing of EE : 60 mg Once daily for up to 8 weeks
OR AS DIRECTED BY THE PHYSICIAN. STORAGE
Store below 300 C temperature & in a dry place, protected from light.
IMPORTANT ADMINISTRATION INFORMATION Keep all medicines out of reach of children.
• DDR (Dexlansoprazole) can be taken without regard to food.
• DDR (Dexlansoprazole) should be swallowed whole. PACKING
• Alternatively, DDR (Dexlansoprazole) capsules can be administered as follows: DDR 30 Capsule: Each box contains 6X10 capsules in Alu-Alu blister strips.
− Open capsule DDR 60 Capsule: Each box contains 3X10 capsules in Alu-Alu blister strips.
− Sprinkle intact granules on one tablespoon
− Swallow immediately. * Further information is available on request.
• Granules should not be chewed.
07 1746/02
MISSED DOSE
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too
close to the time of the next dose, only the prescribed dose should be taken at the appointed
time. A double dose should not be taken.
CONTRAINDICATIONS
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component Dhulivita, Dhamrai, Dhaka, Bangladesh
of the formulation.